Job Summary: The Senior Officer - Process Validation (QMS) plays a crucial role in 
ensuring the quality and compliance of pharmaceutical processes within the company. 
This position primarily focuses on developing, implementing, and maintaining robust 
Quality Management Systems (QMS) related to process validation. The individual will 
work closely with cross-functional teams to ensure adherence to regulatory standards 
and guidelines. 
Key Responsibilities: 
1. Process Validation: 
?? Develop and execute process validation strategies in accordance with 
regulatory requirements. 
?? Oversee and coordinate validation activities for manufacturing processes, 
ensuring compliance with current Good Manufacturing Practices (cGMP) 
and other relevant standards. 
2. Quality Management Systems (QMS): 
?? Establish, implement, and maintain effective QMS for process validation. 
?? Conduct regular reviews and updates of QMS processes to ensure 
continuous improvement. 
?? Provide training to relevant personnel on QMS procedures and 
compliance requirements. 
3. Documentation and Record Keeping: 
?? Create and maintain comprehensive documentation related to process 
validation activities. 
?? Ensure that all validation records and reports are accurate, complete, and 
in compliance with regulatory standards. 

4. Regulatory Compliance: 
?? Stay informed about changes in regulations and industry standards related 
to process validation. 
?? Collaborate with regulatory affairs to ensure submissions and approvals 
are in line with regulatory requirements. 

5. Cross-Functional Collaboration: 
?? Work closely with manufacturing, quality control, and other relevant 
departments to facilitate efficient and compliant process validation 
activities. 
?? Participate in cross-functional teams to address quality-related issues and 
implement corrective and preventive actions. 

Qualifications and Requirements: 
?? Bachelor's or Master's degree in, Chemistry, or B. Pharma or M. Pharma . 

?? 4 or 7 of experience in pharmaceutical process validation and quality 
management. 
?? Strong knowledge of cGMP, FDA, and other relevant regulatory guidelines. 
?? Excellent communication and interpersonal skills. 
?? Detail-oriented with the ability to manage multiple tasks simultaneously. 
?? Proven ability to work in a cross-functional team environment. 
Preferred Skills: 
?? Experience with statistical tools and analysis for process validation. 
?? Familiarity with risk assessment methodologies. 
?? Knowledge of advanced manufacturing technologies and their validation 
requirements.